Drug Target Review

JUNE 12, 2023

TEAD proteins are known to be very important in cancer progression TEAD proteins are known to be very important in cancer progression, and there are a number of therapies in development. What are the preclinical characteristics of ISM6331, including its efficacy, safety profile, and drug metabolism and pharmacokinetics (DMPK) properties?

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Metabolic Stability Clinical Trials Small Molecule Therapies 92

Alta Sciences

OCTOBER 30, 2023

TOP NONCLINICAL SCIENTIFIC RESOURCES eBook : Safety Assessment for Ophthalmic Products Designing preclinical studies for ocular therapies take a lot of deliberation. The Altascientist : Issue No. Read or listen now. TOP MANUFACTURING AND ANALYTICAL RESOURCES The Altascientist : Issue No. Watch it now. The Altascientist : Issue No.

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Science Clinical Trials Pharmacokinetics Pharmacy 52

PPD

OCTOBER 12, 2023

Cell and gene therapies (CGTs) are one of the fastest growing areas in human therapeutics. Since chimeric antigen receptor T cell (CAR-T) therapy was first approved in 2017, there has been a marked increase of cell and gene therapy studies resulting in significant changes in the way diseases are treated as well as patient outcomes.

Laboratories 52

Laboratories Clinical Trials Protein Expression Pharmacokinetics 52

New Drug Approvals

DECEMBER 24, 2023

1] It was developed to treat hereditary transthyretin amyloidosis by Ionis Pharmaceuticals and AstraZeneca. [2] Ionis Pharmaceuticals. “Characteristics of Patients with Hereditary Transthyretin Amyloidosis-Polyneuropathy (ATTRv-PN) in NEURO-TTRansform, an Open-label Phase 3 Study of Eplontersen” Neurology and Therapy.

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Clinical Trials FDA Clinical Pharmacology FDA Approval 62

The Pharma Data

NOVEMBER 4, 2020

–( BUSINESS WIRE )– Concert Pharmaceuticals, Inc. Food and Drug Administration (FDA) Breakthrough Therapy and Fast Track Designations, is now in pivotal testing, and CTP-692 for schizophrenia is currently on track for topline data readout in the first quarter of 2021,” said Roger Tung, Ph.D., 5, 2020 11:00 UTC. .

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The Pharma Data

DECEMBER 9, 2020

EDISON, NJ / ACCESSWIRE / December 10, 2020 / Hepion Pharmaceuticals, Inc. ” About Hepion Pharmaceuticals. Hepion Pharmaceuticals is a clinical stage biopharmaceutical company focused on the development of targeted therapies for the treatment of non-alcoholic steatohepatitis (NASH) and other liver diseases.

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The Pharma Data

JULY 6, 2021

New research from first-in-class marketed and investigational therapies in hemophilia, immune thrombocytopenia and acquired thrombotic thrombocytopenic purpura will be presented. Sanofi’s two marketed extended half-life factor replacement therapies shifted a two-decades-old treatment paradigm when launched in 2014.

Therapies 52

Therapies Pharmacokinetics Treatment RNA 52

The Pharma Data

JUNE 28, 2021

Current guidelines are limited and recommend treating pediatric patients with or at risk for reoccurrence of blood clots with standard anticoagulation therapy which requires injections, dietary restrictions, and regular laboratory monitoring. by Janssen Pharmaceuticals, Inc. Study The randomized, open-label phase III EINSTEIN-Jr.

FDA 52

FDA Clinical Trials Treatment Therapies 52

New Drug Approvals

APRIL 18, 2025

potassium hydroxide), and water to prepare 4-(2-chloro-4-methoxy-5-methylphenyl)-N-[(1S)-2-cyclopropyl-1-(3-fluoro-4-methylphenyl)ethyl]-5-methyl-N-prop-2-ynyl-1,3-thiazol-2-amine (Compound 1) or a pharmaceutically acceptable salt thereof is provided below in Scheme VII. New Drug Therapy Approvals 2024 (PDF). 1 December 2024.

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FDA FDA Approval Drugs Trials 62

The Pharma Data

MARCH 13, 2021

Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that it has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for lanadelumab subcutaneous injection, a monoclonal antibody therapy for prophylaxis against attacks of hereditary angioedema (HAE).

Treatment 52

Treatment Pharmacokinetics Drugs Production 52

The Pharma Data

MARCH 22, 2021

Tominersen, previously IONIS-HTTRx or RG6042, is an investigational antisense therapy designed to reduce the production of all forms of the huntingtin protein (HTT), including its mutated variant, mHTT. In December 2017, Roche licensed the investigational molecule from Ionis Pharmaceuticals. About Roche in Neuroscience.

Disease 52

Disease Clinical Trials Pharmacokinetics Treatment 52

The Pharma Data

APRIL 4, 2023

Biosimilars help patients to gain broader access to effective and high-quality treatments that improve their disease therapies,” said Rebecca Guntern, Head of Region Europe, Sandoz. The study met all its primary objectives, demonstrating comparable pharmacokinetics and showing similar safety and immunogenicity between the two concentrations.

Biosimilars 40

Biosimilars Pharmacokinetics FDA Approval Packaging 40

New Drug Approvals

APRIL 19, 2025

0004]The synthesis of Landiolol 1 is disclosed in US 5013734 , JP 3302647 , CN 100506814 , JP 2539734 and Chemical & Pharmaceutical Bulletin 1992, 40 (6) 1462-1469. “Pharmacokinetics of landiolol hydrochloride, a new ultra-short-acting beta-blocker, in patients with cardiac arrhythmias” Clinical Pharmacology and Therapeutics.

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FDA Clinical Trials Treatment Trials 62

The Pharma Data

MARCH 25, 2022

Some 40% of approved pharmaceutical products in use today derive from natural substances, highlighting the vital importance of conserving biodiversity and sustainability. Artificial intelligence is now used to map evidence and trends in traditional medicine and to screen natural products for pharmacokinetic properties.

Government 52

Government Science Pharmacokinetics Production 52

New Drug Approvals

SEPTEMBER 13, 2024

4] [6] Aticaprant was originally developed by Eli Lilly , was under development by Cerecor for a time, and is now under development by Janssen Pharmaceuticals. [2] 14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] 14] Pharmacokinetics The oral bioavailability of aticaprant is 25%. [1] nM vs. 24.0

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Treatment Clinical Trials Pharmacokinetics Pharmaceuticals 62

Drug Target Review

OCTOBER 8, 2024

DOTA’s strong binding affinity to metal ions such as ¹⁷⁷Lu and other medical radioisotopes used for therapeutic or diagnostic purposes, along with its demonstrated safety profile in approved radioligand therapies, has made it the most widely used chelator in pretargeting strategies to date. With a half-life of approximately 6.7

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Pharmacokinetics Engineering Treatment Science 52

New Drug Approvals

OCTOBER 24, 2023

1] Etrasimod was discovered by Arena Pharmaceuticals , with subsequent development by Pfizer. [2] “Etrasimod as induction and maintenance therapy for ulcerative colitis (ELEVATE): two randomised, double-blind, placebo-controlled, phase 3 studies” Lancet. 1] It is taken by mouth. [1] 401 (10383): 1132–1133. PMID 36871570.

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FDA FDA Approval International Pharmacokinetics 57

The Pharma Data

AUGUST 19, 2021

The Janssen Pharmaceutical Companies of Johnson & Johnson today announced preliminary data from the Phase 1 CHRYSALIS study evaluating RYBREVANT TM (amivantamab-vmjw) for the treatment of patients with non-small cell lung cancer (NSCLC) with mesenchymal-epithelial transition (MET) exon 14 skipping (METex14) mutations. 4] , [5] , [6].

Treatment 52

Treatment FDA Approval Pharmacokinetics FDA 52

Alta Sciences

SEPTEMBER 13, 2023

COMMONLY USED PAIN MODELS As pain models continue to expand, there are still many tried and tested ways to achieve the most accurate results possible, such as pain stimulation, pharmacodynamics (PD), and pharmacokinetics (PK) for early phase analgesic trials. Discover four models used by scientists at Altasciences to ensure accurate results.

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Clinical Trials Treatment Trials Drug Development 52

The Pharma Data

DECEMBER 29, 2020

Of the 22 patients enrolled in the BRIDGE study, the majority of treatment emergent adverse events were mild or moderate in severity, with two patients (9.1%) withdrawing from the therapy due to hypersensitivity reaction that was resolved. The most common moderate treatment emergent adverse events were nasopharyngitis, headache and dyspnea.

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Clinical Trials Disease Treatment Trials 52

The Pharma Data

SEPTEMBER 19, 2020

Tecentriq is approved in the US, EU and countries around the world, either alone or in combination with targeted therapies and/or chemotherapies in various forms of non-small cell and small cell lung cancer, certain types of metastatic urothelial cancer and in PD-L1-positive metastatic triple-negative breast cancer.

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The Pharma Data

AUGUST 21, 2020

It’s a coalition of globally renowned academic institutions, pharmaceutical companies and nonprofit research organizations. And then the long-term goal of the project is to develop new therapies for the SARS-CoV-2 virus at the root of COVID-19, as well as other coronaviruses which could cause future pandemics.

Virus 52

Virus Small Molecule Licensing Licensing 52

The Pharma Data

NOVEMBER 26, 2020

Priority Review is granted to therapies that the FDA determines have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions. About Pegunigalsidase Alfa. Galactosidase-A enzyme. About Protalix BioTherapeutics, Inc.

Disease 52

Disease Treatment Clinical Trials FDA 52

The Pharma Data

DECEMBER 15, 2020

The clinical responses were sustained by maintenance therapy with belimumab, an antibody to B-cell activating factor. The secondary outcome involves pharmacokinetic endpoints. 2 g/dl on three consecutive available visits during the 24-week treatment period, with the response not being attributed to rescue therapy.

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Disease Clinical Trials Small Molecule Trials 52

The Pharma Data

JANUARY 17, 2021

18, 2021 /PRNewswire/ — Genkyotex SA , a subsidiary of Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX; NASDAQ – CALT), today announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex’s lead asset. STOCKHOLM , Jan.

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Trials Clinical Trials Pharmacokinetics Small Molecule 40

The Pharma Data

JULY 11, 2021

For more than a decade, we’ve listened to the HAE community to further understand the need for long-term, preventive targeted therapies and have committed our resources to developing treatment options,” said Neil Inhaber, M.D., Analysis of Safety and Efficacy for up to 2.5 Vice President, Global Medical Head, HAE and Transplant at Takeda.

Treatment 52

Treatment Pharmacokinetics Disease Production 52

The Pharma Data

DECEMBER 5, 2020

Regeneron Pharmaceuticals, Inc. ” In the trial, the 49 patients evaluated had a median of five prior lines of therapy (range: 2-17) with 100% being triple-refractory and 57% being penta-refractory; all patients were refractory to anti-CD38 therapy. About Regeneron Pharmaceuticals, Inc. With a median follow up of 2.6

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The Pharma Data

NOVEMBER 22, 2020

Preclinical data support MP0420’s potential efficacy as both a prophylactic and as an acute therapy. MP0420 is designed to bind the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein at three distinct locations to prevent viral entry into cells. Chief Medical Officer of Molecular Partners.

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Trials Clinical Trials Licensing Licensing 40

The Pharma Data

JANUARY 10, 2021

Development of TransCon CNP is progressing as planned with the recent initiation by VISEN Pharmaceuticals of a second phase 2 trial in patients with achondroplasia, the ACcomplisH China Trial, which provides for dose expansion at an effective dose determined from the ACcomplisH Trial. . •. ?.

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Clinical Trials Clinical Development Small Molecule Trials 40

The Pharma Data

JULY 22, 2021

Takeda Pharmaceutical Company Limited ( TSE: 4502 /NYSE:TAK) (“Takeda”) today announced the results of a phase 3 trial investigating the efficacy and safety of recombinant von Willebrand factor (rVWF) prophylaxis, 1 one of the 12 abstracts being presented at the International Society on Thrombosis and Haemostasis (ISTH) Virtual Congress 2021.

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The Pharma Data

DECEMBER 13, 2020

The Phase 2b trial will also evaluate efficacy on other histology endpoints (fibrosis), assessment of metabolic and non-metabolic parameters, pharmacokinetic assessment as well as safety and tolerability. Currently no curative or specific therapies are available. The Phase 2b trial is expected to begin during the second half of 2021.

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Agency IQ

FEBRUARY 23, 2024

Additionally, this approach is generally no longer applicable to new treatments that are more targeted in their effects, such as immunotherapies and targeted small molecule therapies. This has spawned a movement focused on optimizing dose selection in oncology drug development. We need to think [now] that not always MTD is the approach.”

Science 40

Science FDA Trials Clinical Pharmacology 40

The Pharma Data

OCTOBER 27, 2020

In October 2020 , we completed a second clinical study in healthy volunteers to compare the pharmacokinetics of Treprostinil Technosphere to Tyvaso. The phase 3 ADVANCE OUTCOMES study (NCT03626688) seeks to evaluate approximately 700 PAH patients, randomized 1:1 between oral ralinepag and placebo along with background therapy.

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Drug Target Review

JUNE 5, 2023

It also displayed favourable pharmacokinetics (PK) and is well tolerated in non-human primates (NHP) at exposure levels above those projected to be efficacious. ZW191 also displayed favourable pharmacokinetics (PK) and is well tolerated in non-human primates (NHP) at exposure levels above those projected to be efficacious.

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PPD

APRIL 14, 2025

Medical researchers and practitioners see in their own patients how these ailments interconnect and overlap, as do the pharmaceutical and biotech companies working to develop GLP-1 therapeutics. This expansion is creating opportunities for clinical trials related to a range of new therapy areas and their subpopulations.

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Clinical Trials Trials Clinical Development Disease 52

DrugBank

FEBRUARY 26, 2025

In response, researchers and pharmaceutical companies are exploring novel approaches to antibiotic development. Over the past two decades, many pharmaceutical companies have deprioritized antibiotic research due to high development costs and lower profitability compared to treatments for chronic diseases.

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Therapies Pharmaceutical Companies Pharmacokinetics Treatment 52

The Pharma Data

JULY 21, 2021

In the ongoing Phase 2a (NCT04003103) randomized, double-blind, parallel assignment, placebo-controlled, multicenter trial in adults at low-risk for acquiring HIV-1 infection, participants were randomly assigned (2:2:1) to one of three oral once-monthly therapy groups: islatravir 60 mg, islatravir 120 mg or placebo.

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